Melphalan Export Market Intelligence: India's 153 Suppliers Shipping to 97 Countries — TransData Nexus 2026

Q: Who are the top melphalan exporters from India?

The top melphalan exporters from India are: 1. EMCURE PHARMACEUTICALS LIMITED — $8.8M (69.3% market share); 2. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $1.0M (8.0% market share); 3. GLAND PHARMA LIMITED — $539.6K (4.2% market share); 4. EMCURE PHARMACEUTICALS LTD — $443.8K (3.5% market share); 5. INVEX HEALTH PRIVATE LIMITED — $231.4K (1.8% market share). Together they account for 86.9% of India's total melphalan export value.

Q: What is the total export value of melphalan from India?

The total export value of melphalan from India is $12.8M USD, recorded across 838 shipment transactions from 153 active exporters to 97 destination countries. The average shipment value is $15.2K.

Q: Which countries import melphalan from India?

India exports melphalan to 97 countries worldwide. The top importing countries are: RUSSIA (23.4% share, $3.0M), UNITED KINGDOM (21.3% share, $2.7M), MALTA (9.5% share, $1.2M), CANADA (7.7% share, $978.9K), UNITED STATES (7.6% share, $968.4K). These five markets account for 69.5% of total export value.

Q: What is the HS code for melphalan exports from India?

The primary HS code for melphalan exports from India is 30049049. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) for tracking and reporting pharmaceutical trade flows.

Q: What is the average price of melphalan exports from India?

The average unit price for melphalan exports from India is $19.81 USD per unit, with prices ranging from $0.01 to $141.34 depending on formulation, packaging, and order volume. The total market is valued at $12.8M across 838 shipments.

Q: Which ports handle melphalan exports from India?

The primary ports for melphalan exports from India are SAHAR AIR (28.4% of shipments), SAHAR AIR CARGO ACC (INBOM4) (23.7% of shipments), Bombay Air (6.2% of shipments), DELHI AIR (5.8% of shipments), DELHI AIR CARGO ACC (INDEL4) (4.3% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Q: Why is India a leading exporter of melphalan?

India is one of the world's leading exporters of melphalan due to its large base of 153 WHO-GMP and US FDA approved manufacturers, significantly lower production costs compared to Western markets, well-established API (Active Pharmaceutical Ingredient) supply chains, and strong government support for pharmaceutical exports through the Pharmaceuticals Export Promotion Council (Pharmexcil). India exports melphalan to 97 countries, demonstrating 50% global market coverage.

Q: What certifications do Indian melphalan exporters need?

Indian melphalan exporters typically require WHO-GMP (Good Manufacturing Practice) certification for most regulated markets, US FDA approval for exports to the United States, EU GMP certification for European markets, and country-specific regulatory approvals for markets in Africa, Asia, and Latin America. Additional certifications may include ISO 9001, Schedule M compliance under Indian drug laws, and Free Sale Certificates issued by the Central Drugs Standard Control Organization (CDSCO).

Q: How many buyers import melphalan from India?

There are 272 registered buyers importing melphalan from India, spread across 97 countries. The repeat buyer rate is 48.5%, indicating strong long-term trade relationships and consistent product quality.

Q: What is the market share of the top melphalan supplier from India?

EMCURE PHARMACEUTICALS LIMITED is the leading melphalan exporter from India with a market share of 69.3% and total export value of $8.8M across 221 shipments. The top 5 suppliers together control 86.9% of total export value.

Suresh Sormare

Melphalan

India Pharmaceutical Trade Intelligence

$12.8M153 Suppliers97 CountriesHS 30049049

ExportsIndia → RUSSIA23.4%India → UNITED KINGDOM21.3%

ImportsUNITED STATES → India$43.2K CANADA → India$38.8K

#1 Supplier: EMCURE PHARMACEUTICALS

Melphalan Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Melphalan to the World

Between 2022 and 2026, India exported $12.8M worth of melphalan across 838 verified shipments to 97 countries — covering 50% of world markets in the Advanced Oncology segment. The largest destination is RUSSIA (23.4%). EMCURE PHARMACEUTICALS LIMITED leads with a 69.3% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published March 2026·Updated March 2026·

Melphalan export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Melphalan export data snapshot — $12.8M · 153 exporters · 97 countriesTransData Nexus · Indian Customs Data

Top Melphalan Exporters from India

153 active exporters · Ranked by export value

View all 153 →

Top Melphalan Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	EMCURE PHARMACEUTICALS LIMITED	$8.8M	221	18	69.3%
2	SUN PHARMACEUTICAL INDUSTRIES LIMITED

Top Countries Importing Melphalan from India

97 destination markets · Ranked by import value

All 97 countries →

Top Countries Importing Melphalan from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	RUSSIA	$3.0M	23.4%
2	UNITED KINGDOM	$2.7M	21.3%
3	MALTA	$1.2M	9.5%
4	CANADA	$978.9K	7.7%
5	UNITED STATES	$968.4K	7.6%
6	BELGIUM	$653.2K	5.1%
7	SOUTH KOREA	$566.5K	4.4%
8	SAUDI ARABIA	$352.7K	2.8%
9	TURKEY	$233.9K	1.8%
10	ITALY	$218.0K	1.7%

RUSSIA is India's largest melphalan export destination, absorbing 23.4% of total exports worth $3.0M. The top 5 importing countries — RUSSIA, UNITED KINGDOM, MALTA, CANADA, UNITED STATES — together account for 69.5% of India's total melphalan export value. The remaining 92 destination countries collectively receive the other 30.5%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Melphalan to India?

4 origin countries · Total import value: $87.1K

India imports melphalan from 4 countries with a combined import value of $87.1K. The largest supplier is UNITED STATES ($43.2K, 6 shipments), followed by CANADA and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Melphalan to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$43.2K	6	49.6%
2	CANADA	$38.8K	5	44.6%
3	GERMANY	$3.8K	3	4.4%
4	IRELAND	$1.2K	1	1.4%

UNITED STATES is the largest supplier of melphalan to India, accounting for 49.6% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Melphalan

Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026

1FDA & US Market Regulatory Status

In the United States, melphalan is approved for the treatment of multiple myeloma and ovarian cancer. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for melphalan, indicating a competitive generic market. Notably, on August 14, 2023, the FDA approved Hepzato (melphalan) for the treatment of uveal melanoma with unresectable hepatic metastases. This approval underscores the ongoing therapeutic relevance of melphalan in oncology. Given that 153 Indian exporters are actively involved in melphalan exports, compliance with FDA regulations, including adherence to Current Good Manufacturing Practices (cGMP) and obtaining necessary approvals, is imperative for market access.

2EU & UK Regulatory Framework

Within the European Union, melphalan is authorized for use in multiple myeloma and ovarian cancer treatments. The European Medicines Agency (EMA) granted marketing authorization for Phelinun (melphalan hydrochloride) on November 16, 2020. This authorization is valid across all EU member states, including the United Kingdom at that time. Post-Brexit, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) continues to recognize EMA approvals; however, UK-specific regulatory requirements may apply. Manufacturers exporting to these regions must comply with EU Good Manufacturing Practice (GMP) standards to ensure product quality and safety.

3WHO Essential Medicines & Global Standards

Melphalan is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its critical role in healthcare systems worldwide. This inclusion facilitates its adoption and procurement by various countries, especially those relying on WHO guidelines for essential medicines. Additionally, melphalan is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality parameters across different jurisdictions.

4India Regulatory Classification

In India, melphalan is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, melphalan is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national and international regulations.

5Patent & Exclusivity Status

The primary patents for melphalan have expired, leading to a robust generic market with multiple manufacturers producing the drug. This competitive landscape has contributed to its widespread availability and affordability. However, specific formulations or novel delivery methods may still be under patent protection, necessitating due diligence by exporters to avoid infringement.

6Recent Industry Developments

In August 2023, the FDA approved Hepzato (melphalan) for the treatment of uveal melanoma with unresectable hepatic metastases, expanding the therapeutic applications of melphalan. In September 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a variation to the marketing authorization of Pepaxti (melphalan flufenamide), indicating ongoing regulatory activities concerning melphalan derivatives. These developments reflect the dynamic regulatory landscape and the importance of staying informed about policy changes and approvals affecting melphalan's market presence.

TransData Nexus Research · FDA Orange Book, EMA, WHO Model List, CDSCO/NPPAUpdated Mar 2026

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Global Price Benchmark — Melphalan

Retail & reference prices across 9 markets vs. India FOB export price of $19.81/unit

Global Price Benchmark for Melphalan across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$278.59	USD	Pricing data sourced from Drugs.com.
United Kingdom	N/A	GBP	Specific pricing information for melphalan in the UK is not readily accessible.
Germany	N/A	EUR	Specific pricing information for melphalan in Germany is not readily accessible.
Australia	N/A	AUD	Specific pricing information for melphalan in Australia is not readily accessible.

Supply Chain Risk Assessment — Melphalan

API sourcing, concentration risk, storage requirements, and current alerts

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, often referred to as the "pharmacy of the world," heavily relies on China for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Approximately 70% of India's API and KSM requirements are imported from China, creating a significant dependency. This reliance poses substantial risks, as any disruption in Chinese supply chains can directly impact India's pharmaceutical production capabilities.

Recent geopolitical tensions have exacerbated these vulnerabilities. In February 2026, the U.S. and Israel launched military operations against Iran, leading to Iran's blockade of the Strait of Hormuz—a critical maritime chokepoint. This blockade has severely disrupted global supply chains, including the transportation of pharmaceutical raw materials. The closure of the strait has been described as the largest disruption to the energy supply since the 1970s energy crisis, significantly affecting the availability and cost of essential inputs for drug manufacturing.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates a high supplier concentration for Melphalan exports from India. The top five exporters account for 86.9% of the total export value, with EMCURE PHARMACEUTICALS LIMITED alone contributing 69.3%. Such concentration increases the risk of supply disruptions, as reliance on a limited number of suppliers can lead to significant vulnerabilities if any of these entities face operational challenges.

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Frequently Asked Questions — Melphalan Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top melphalan exporters from India?

The leading melphalan exporters from India are EMCURE PHARMACEUTICALS LIMITED, SUN PHARMACEUTICAL INDUSTRIES LIMITED, GLAND PHARMA LIMITED, and 7 others. EMCURE PHARMACEUTICALS LIMITED leads with 69.3% market share ($8.8M). The top 5 suppliers together control 86.9% of total export value.

What is the total export value of melphalan from India?

The total export value of melphalan from India is $12.8M, recorded across 838 shipments from 153 active exporters to 97 countries. The average shipment value is $15.2K.

Which countries import melphalan from India?

India exports melphalan to 97 countries. The top importing countries are RUSSIA (23.4%), UNITED KINGDOM (21.3%), MALTA (9.5%), CANADA (7.7%), UNITED STATES (7.6%), which together account for 69.5% of total export value.

What is the HS code for melphalan exports from India?

The primary HS code for melphalan exports from India is 30049049. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) to track and report pharmaceutical export flows.

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical Export-Import Analyst & Trade Intelligence Expert

Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.

linkedin.com/in/sureshsormare

Primary Data Source

All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.

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Melphalan

Top Melphalan Exporters from India

Top Countries Importing Melphalan from India

Who Supplies Melphalan to India?

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Regulatory Landscape — Melphalan

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Global Price Benchmark — Melphalan

Supply Chain Risk Assessment — Melphalan

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Melphalan Trade Intelligence

Frequently Asked Questions — Melphalan Exports from India

Who are the top melphalan exporters from India?

What is the total export value of melphalan from India?

Which countries import melphalan from India?

What is the HS code for melphalan exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of melphalan exports from India?

Which ports handle melphalan exports from India?

Why is India a leading exporter of melphalan?

What certifications do Indian melphalan exporters need?

How many buyers import melphalan from India?

What is the market share of the top melphalan exporter from India?

Analysis Methodology